Sustained-release intravitreal liquid drug delivery using triamcinolone acetonide for cystoid macular edema in retinal vein occlusion.

PURPOSE: To investigate side effects seen with this formulation and to search for evidence of effectiveness after a single intravitreal injection of IBI-20089 in eyes with cystoid macular edema (CME) secondary to retinal vein occlusion. DESIGN: Prospective, phase 1 clinical trial. PARTICIPANTS: Ten patients with chronic CME resulting from retinal vein occlusion. METHODS: Patients received a single intravitreal injection of IBI-20089 using a sequential dose escalation schedule. Each cohort consisted of 5 patients who received the intravitreal injection of the sustained liquid drug delivery system containing either 6.9 mg (25 µl) triamcinolone acetonide (TA; cohort 1) or 13.8 mg (50 µl) TA (cohort 2). At each study visit, best-corrected visual acuity testing, slit-lamp biomicroscopy, IOP measurement, dilated ophthalmoscopy, fundus photography and optical coherence tomography (OCT) were performed. Patients also underwent laboratory testing and physical examinations to monitor for any systemic adverse events. MAIN OUTCOME MEASURES: Optical coherence tomography central subfield thickness, ocular and systemic adverse events. RESULTS: In cohort 1, mean baseline OCT central subfield thickness (CST) was 477 µm and decreased to 369 µm at day 1 (P<0.06), 387 µm at day 30 (P = 0.18), and 251 µm at day 360 (P = 0.46). In cohort 2, mean baseline OCT CST was 518 µm and decreased to 404 µm at day 1 (P = 0.134), 289 µm at day 30 (P = 0.003), 207 µm at day180 (P = 0.004), and 278 µm at day 360 (P = 0.009). Related adverse events included elevation of IOP in 3 patients, in 2 because of neovascular glaucoma (not related to study drug) and in 1 who required a glaucoma tube shunt. CONCLUSIONS: A single intravitreal injection of IBI-20089 resulted in a controlled and sustained delivery of a TA. Side effects included elevated IOP in 3 eyes, 2 of which had neovascular glaucoma.

One year results of a phase 1 study of the safety and tolerability of combination therapy using sustained release intravitreal triamcinolone acetonide and ranibizumab for subfoveal neovascular AMD.

PURPOSE: To investigate safety and evidence of efficacy of IBI-20089, an intravitreal, liquid, sustained drug delivery system formulated with triamcinolone acetonide (TA) in combination with ranibizumab (Lucentis) for neovascular age related macular degeneration. METHODS: Patients received a single intravitreal injection of IBI-20089 containing either 6.9 mg (25 µL) TA or 13.8 mg (50 µL) TA followed a week later by intravitreal injection of 0.5 mg ranibizumab. Patients were followed monthly and underwent best corrected visual acuity testing, slit lamp biomicroscopy, dilated ophthalmoscopy, fundus photos and optical coherence tomography. Patients received pro re nata dosing of ranibizumab. RESULTS: Patients ranged in age from 59 years to 81 years (mean 73.4 years) and all completed 1 year follow-up. No serious related adverse events occurred. Ocular adverse events included mild, transient, elevated intraocular pressure in eight patients and cataract progression in three of the five phakic patients. At 1 year, 30 of a total 120 (25%) possible pro re nata re-Rx's had been given. Combination therapy resulted in a median number of 3.5 re-treatments at and including month 12. CONCLUSIONS: Combination therapy IBI-20089 and ranibizumab was well-tolerated and resulted in fewer ranibizumab retreatments. Transient intraocular pressure elevation and cataract progression occurred. TRIAL REGISTRATION NUMBER: NCT01175395.